The following data is part of a premarket notification filed by Stedim, Inc. with the FDA for Automix Compounder Vented Spike Adaptor.
| Device ID | K890204 |
| 510k Number | K890204 |
| Device Name: | AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | STEDIM, INC. 3667 PERADA DR. Walnut Creek, CA 94598 |
| Contact | Bryan L Krause |
| Correspondent | Bryan L Krause STEDIM, INC. 3667 PERADA DR. Walnut Creek, CA 94598 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1989-10-27 |